Abstract:
:Objectives: Ethics guidelines such as the Declaration of Helsinki and the CIOMS International Ethical Guidelines for Health-related Research Involving Humans require the sponsors, in cooperation with relevant stakeholders, to provide post-trial access (PTA) to intervention and knowledge, especially in clinical trials held in resource-poor regions. To date, we have very limited knowledge in terms of whether PTA is provided at all, and in what form. To partially address this current limitation, this study wished to explore whether, for which type of drugs and in what form PTA is provided in the Philippines. Methods: We looked at all the clinical trial protocols submitted to the University of the Philippines Manila from 2012 to 2017. A total of 193 clinical trial protocols were included in the study. To identify whether, for which drug type and in what form PTA is provided, we gathered the following information: start and end date of the trial, name of study drug, tested indication of the study drug, region the sponsor is from, type/category of the study drug, type of funding agency, provisions for PTA (yes or no) and the explanation for the provisions. PTA provisions were further described according to the form in which PTA was provided and the types of drugs that were given PTA. Results: Of the 193 protocols, 51.81% indicated PTA, though PTA in the form identified in guidelines can be partially accounted for in only 29.5% (57). The most common form of PTA is the provision or sharing of information (40). None of the protocols provided PTA in the form of access to intervention after the trials, with the possible exemption of 10 protocols that declared future evaluation of the sponsor for PTA depending on patient need, and another seven that might offer the option to transfer to an open-label extension study after the trial. Conclusion: More work is needed if PTA, as stipulated in ethics guidelines, is to be reflected in reality.
journal_name
Curr Med Res Opinjournal_title
Current medical research and opinionauthors
Jimenez EB,Virtudazo JMP,Torres CE,Bernabe RDdoi
10.1080/03007995.2019.1644851subject
Has Abstractpub_date
2019-11-01 00:00:00pages
1849-1855issue
11eissn
0300-7995issn
1473-4877journal_volume
35pub_type
杂志文章,评审abstract:OBJECTIVE:To review the fatalities among children hospitalized with respiratory syncytial virus (RSV) infection, and identify factors leading to a fatal outcome. RESEARCH DESIGN AND METHODS:Review of literature identified from a structured search of PubMed (1966-2009) using the following Medical Subject Headings: resp...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2010.505126
更新日期:2010-09-01 00:00:00
abstract::Olanzapine (2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5] benzodiazepine) is a novel antipsychotic agent of the theinobenzodiazepine class developed by Eli Lilly & Co. It has a pleotrophic pharmacology and affects the dopaminergic, serotonergic, muscarinic and adrenergic systems. The therapeutic advantage...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007999909113367
更新日期:1999-01-01 00:00:00
abstract:OBJECTIVE:To compare the analgesic efficacy and safety of oxymorphone extended release (ER) and oxycodone controlled release (CR) in patients with moderate to severe cancer pain. RESEARCH DESIGN AND METHODS:This randomized, multicenter, double-blind, 2-period crossover study included adult outpatients (>or= 18 years o...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1185/030079904125003854
更新日期:2004-06-01 00:00:00
abstract::A double-blind, multi-centre trial was carried out in 191 patients with acute musculoskeletal conditions to compare the efficacy of naproxen and indomethacin. Patients were randomly allocated to receive either 250 mg naproxen or 50 mg indomethacin twice daily. Treatment was for 7 or 14 days. The results, assessed by t...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1185/03007997609109332
更新日期:1976-01-01 00:00:00
abstract::Objective: The purpose of this study was to examine surgical and survival outcomes in the elderly (65-79 years of age) and the very elderly (≥80 years of age) who received surgery for gastric cancer.Methods: This study retrospectively reviewed the records of patients ≥65 years old who received a gastrectomy for gastri...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2018.1520083
更新日期:2020-02-01 00:00:00
abstract:BACKGROUND:Untreated and under-treated pain represent one of the most pervasive health problems, which is worsening as the population ages and accrues risk for pain. Multiple treatment options are available, most of which have one mechanism of action, and cannot be prescribed at unlimited doses due to the ceiling of ef...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1080/03007995.2017.1310092
更新日期:2017-06-01 00:00:00
abstract:OBJECTIVE:The clinical relevance of pro- and hyperalgesic effects of opioids is still a matter of debate. Particularly for remifentanil, an increased postoperative need for analgesics has been demonstrated suggesting opioid-induced hyperalgesia as a possible cause. The aim of the study was therefore to investigate the ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1080/03007995.2016.1211517
更新日期:2016-11-01 00:00:00
abstract:BACKGROUND:In TRITON-TIMI 38, patients with acute coronary syndromes were treated with prasugrel or clopidogrel, with aspirin, for a median of 14.5 (maximum of 15) months. Based on this trial, the EU label for prasugrel recommends treatment for up to 12 months and excludes patients with prior stroke/transient ischemic ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/03007995.2014.944638
更新日期:2014-11-01 00:00:00
abstract:OBJECTIVE:The purpose of this study was to examine how lifestyle behaviors in the context of physical activity levels and screen time are associated with school absenteeism. METHODS:We analyzed 2005-2008 NHANES data of proxy interviews for 1048 children aged 6-11 years and in-person self-reports of 1117 adolescents ag...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2015.1135112
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVE:To explore relationships between beta-cell function and incident cardiovascular events, death, and medical costs among elderly individuals. RESEARCH DESIGN AND METHODS:In a prospective, population-based cohort of 4555 elderly individuals, we examined the effect of beta-cell function on incident cardiovascula...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究
doi:10.1185/030079908x253573
更新日期:2008-01-01 00:00:00
abstract:OBJECTIVE:To evaluate the relative efficacy and safety of extended-release tramadol HCl 75 mg/acetaminophen 650 mg (TA-ER) and immediate-release tramadol HCl 37.5 mg/acetaminophen 325 mg (TA-IR) for the treatment of moderate to severe acute pain following total knee replacement. METHODS:This phase III, double-blind, p...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1185/03007995.2014.975338
更新日期:2015-01-01 00:00:00
abstract:OBJECTIVE:Chronic respiratory failure (CRF) is a syndrome defined by certain disturbances in arterial blood gases. Non-invasive mechanical ventilation (NIMV) is an increasingly used treatment modality in respiratory failure. The aim of this study was to investigate the long-term effects of NIMV on pulmonary function an...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2010.508703
更新日期:2010-09-01 00:00:00
abstract:OBJECTIVE:To investigate the associations between obesity and any significant improvements in glycemic control, blood pressure, and lipid targets in Chinese patients with concomitant type 2 diabetes mellitus (T2DM) and hypertension. METHODS AND RESULTS:A total of 3041 dyslipidemia patients with an average age of 65.7 ...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2015.1058770
更新日期:2015-01-01 00:00:00
abstract:BACKGROUND:The rising prevalence of nosocomial methicillin-resistant Staphylococcus aureus (MRSA) and the recent emergence of community-associated MRSA are major clinical, public health, and economic challenges. MRSA is a leading cause of nosocomial pneumonia and complicated skin and soft-tissue infections (cSSTI). Van...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007990903512057
更新日期:2010-03-01 00:00:00
abstract:OBJECTIVE:Early involvement of specialists is associated with improved survival in ovarian cancer patients. However, only 33-60% of patients are currently being referred. A more effective strategy to get patients with an elevated risk of ovarian cancer to gynecologic oncologists is needed. The objective of this study w...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2016.1176014
更新日期:2016-06-01 00:00:00
abstract:OBJECTIVE:To compare the risk of developing uveitis in patients initiating anti-tumor necrosis factor (anti-TNF) agents (adalimumab, etanercept, and infliximab) for ankylosing spondylitis (AS). METHODS:Anti-TNF-naive patients with a diagnosis of AS and without a history of uveitis (N = 2115) who subsequently initiated...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007995.2014.969368
更新日期:2014-12-01 00:00:00
abstract::The results of recent clinical trials with rivastigmine show that in the approved indication of mild to moderate Alzheimer's disease (AD), the drug is effective in the long term. Rivastigmine produces a significant delay in the decline of the three components of AD that have been identified by European guidelines as e...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/0300799039117029
更新日期:2003-01-01 00:00:00
abstract:OBJECTIVE:To explore the clinical effect and radial remodeling of transradial slender 7 Fr sheath for left main bifurcation disease (LM bifurcation). METHODS:From January 2018 to September 2019, 236 patients with LM bifurcation undergoing transradial percutaneous coronary intervention (PCI) from two heart centers were...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2020.1815684
更新日期:2020-10-01 00:00:00
abstract:OBJECTIVES:Previous systematic reviews and meta-analyses of treatments in relapsing-remitting multiple sclerosis (RRMS) derived their findings from either placebo-controlled studies only or separately from head-to-head and comparative studies. The purpose of this study is to compare annualized relapse rates (ARR) of fi...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1185/03007995.2012.681637
更新日期:2012-05-01 00:00:00
abstract:OBJECTIVE:This observational study was conducted to document the safety of capecitabine-based adjuvant therapy in patients with resected colon cancer under routine clinical conditions. RESEARCH AND DESIGN METHODS:ML20431 was a prospective, multicenter, non-interventional, observational study. It was designed to answer...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究
doi:10.1185/03007995.2015.1014030
更新日期:2015-04-01 00:00:00
abstract::Evidence from randomized, placebo-controlled, double-masked studies has demonstrated that verteporfin (Visudyne) therapy is effective in reducing the risk of visual acuity loss in selected groups of patients with choroidal neovascularization (CNV) due to age-related macular degeneration (AMD). Pilot studies of intravi...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/030079905X43659
更新日期:2005-05-01 00:00:00
abstract:OBJECTIVE:The dopamine agonist rotigotine has shown efficacy and safety for the treatment of early and advanced Parkinson's disease (PD) in controlled clinical trials. This observational study evaluated rotigotine administration in combination with other antiparkinsonian medication in routine clinical practice. METHOD...
journal_title:Current medical research and opinion
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1185/03007995.2011.611630
更新日期:2011-10-01 00:00:00
abstract:OBJECTIVE:To investigate the use of traditional non-steroidal anti-inflammatory drugs (tNSAIDs) in the management of osteoarthritis (OA) in primary care in Spain and to quantify patient and physician satisfaction with tNSAID therapy. METHODS:A 6-month retrospective, observational study conducted in 29 Spanish primary-...
journal_title:Current medical research and opinion
pub_type: 杂志文章,多中心研究
doi:10.1185/030079903125001712
更新日期:2003-01-01 00:00:00
abstract:BACKGROUND:Breast cancer cells can develop resistance to standard hormonal treatment and chemotherapy with the activation of the mTOR pathway; this is supported by results of preclinical and clinical studies. In clinical trials, the addition of everolimus to hormonal treatment or anti-HER2 treatment improved the outcom...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2013.846253
更新日期:2014-01-01 00:00:00
abstract::Cholinesterase inhibitors, which act by inhibiting the degradation of acetylcholine in the brain, form the mainstay of therapy for AD. Predominant adverse events are cholinergic in nature, the most frequent being gastrointestinal side effects. Here we present a case series of patients with dementia who were treated wi...
journal_title:Current medical research and opinion
pub_type: 信件
doi:10.1185/030079906X162791
更新日期:2007-01-01 00:00:00
abstract:OBJECTIVE:To evaluate four models based on potential predictors for achieving a response to pregabalin treatment for neuropathic pain (NeP). METHODS:In total, 46 pain studies were screened, of which 27 NeP studies met the criteria for inclusion in this analysis. Data were pooled from these 27 placebo-controlled random...
journal_title:Current medical research and opinion
pub_type: 杂志文章,meta分析
doi:10.1080/03007995.2018.1520694
更新日期:2018-12-01 00:00:00
abstract:BACKGROUND:Small cell lung cancer (SCLC) patients, who have achieved complete or partial response after chemotherapy, should be followed with prophylactic cranial irradiation (PCI). PCI for extrapulmonary small cell carcinoma (EPSCC) is not routinely recommended. The purpose of this review is to discuss all aspects of ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,评审
doi:10.1185/03007995.2014.904771
更新日期:2014-07-01 00:00:00
abstract:OBJECTIVE:To compare injection site pain of subcutaneous (sc) epoetin beta and darbepoetin alfa in adult patients with chronic kidney disease. RESEARCH DESIGN AND METHODS:This was a multi-centre, randomised, two-arm, single-blind, cross-over study. Patients were randomised to receive weekly sc darbepoetin alfa 30 mug ...
journal_title:Current medical research and opinion
pub_type: 杂志文章,随机对照试验
doi:10.1185/03007990802240552
更新日期:2008-08-01 00:00:00
abstract::A total of 247 patients suffering from rheumatoid arthritis and allied conditions were referred for routine ophthalmological examination with particular reference to ocular rheumatoid involvement. Of these, 197 were already receiving ibuprofen before their first assessment while 50 had a baseline assessment before com...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1185/03007997609109292
更新日期:1976-01-01 00:00:00
abstract:OBJECTIVE:Schizophrenia is one of the most debilitating diseases in the United Arab Emirates. Oral antipsychotics (OA) are commonly used in terms of pharmacotherapy; however, these treatments can be rendered ineffective by poor patient adherence. Paliperidone palmitate once monthly (PP1M) is a long acting antipsychotic...
journal_title:Current medical research and opinion
pub_type: 杂志文章
doi:10.1080/03007995.2017.1417246
更新日期:2018-04-01 00:00:00